Food, Cosmetic, and Drug Recalls

Date:10/1/2021
Official Message No.:111078-10-1-2021-RECL
Contact Info: Alan | 609-947-8595 | alan.talarsky@doh.nj.gov
Attachments: No

Please review the following message from Alan Talarsky, Environmental Scientist 4, Public Health and Food Protection Program, NJDOH regarding the following Class 1 Recalls issued by the U.S. Food and Drug Administration:

 

1.

All Ultrasound Gels and Lotions by Eco-Med Pharmaceutical: Class I Recall - Due to Risk of Bacteria Contamination

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: All ultrasound gels and lotions manufactured by Eco-Med are being recalled due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). The FDA independently confirmed that distributed product tested positive for bacterial contamination. The use of affected ultrasound gels and lotions contaminated with Bcc may lead to serious infections, including bloodstream infections, which may result in sepsis or death.

As of Aug. 31, 2021, there have been at least 66 infections, including 60 bloodstream infections associated with these affected products, per the Centers for Disease Control and Prevention (CDC).

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Eco-Med ultrasound gels and lotions are used during an ultrasound test to create images of organs and structures inside the body.

RECOMMENDATIONS: On Aug. 4, 2021, Eco-Med Pharmaceutical, Inc. sent a recall classification notice for certain lots of EcoGel, MediChoice, and Mac Medical ultrasound gel. However, the FDA has determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.

The FDA recommends health care providers and facilities:

·         Immediately stop using and discard all ultrasound gel and lotion products manufactured by Eco-Med.

·         Do not purchase ultrasound gels or lotions manufactured by Eco-Med.

·         Consult Centers for Disease Control and Prevention (CDC) and professional society guidelines regarding use of ultrasound gel and appropriate ultrasound cleaning procedures.

·         Contact the distributor that supplied these products to you if you have questions about the disposal of the products.

 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

·         Complete and submit the report online.

·         Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

 

 

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2. Cuisine Innovations Unlimited, LLC of 180 Lehigh Avenue, Lakewood, NJ, is recalling its 8.5-ounce, 6-piece packages of “Vemondo Vegan Crabless Mini Crabcakes” by Lidl because they contain undeclared egg yolks. People who have allergies to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled “Vemondo Vegan Crabless Mini Crabcakes” by Lidl were distributed in retail stores along the East Coast (Delaware, Georgia, Maryland, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Virginia).

The product comes in an 8.5-ounce, 6-piece box marked with either of the following lot#s:  23021 (Exp. Date 2/17/2023), 23121 (Exp. Date 2/18/2023), 23821 (Exp. Date 2/25/2023) and would have been shipped to stores after August 20, 2021.  The UPC Code is:  4056489310402.

No illnesses have been reported to date in connection with this problem.

The recall was initiated after it was discovered that the egg yolk-containing product was distributed in packaging that did not reveal the presence of egg yolks.

There has been no further production of this product.

Consumers who have purchased 8.5-ounce, 6-piece packages of “Vemondo Vegan Crabless Mini Crabcakes” by Lidl are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-201-439-1036, Ext. 26, Monday through Friday, 8 a.m. to 4 p.m. EST.

 

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3.  Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level.  Coppertone has identified the presence of benzene in these lots of products

 

Twelve lots of Coppertone spray products are impacted by this voluntary recall, specifically:

 

UPC

Product Description

Lot

Manufacturing Date

00072140028817

CT P&S BABY SPF50 SPRAY 5OZ 12S

TN0083J

1/10/2021

00072140028817

CT P&S BABY SPF50 SPRAY 5OZ 12S

TN0083K

1/11/2021

00072140028824

CT P&S KIDS SPF50 SPRAY 5OZ 12S

TN00854

1/12/2021

00072140028824

CT P&S KIDS SPF50 SPRAY 5OZ 12S

TN00855

1/14/2021

00072140028701

CT SPORT MIN SPF50 SPRAY 5OZ 12S

TN008KU

3/15/2021

00072140028701

CT SPORT MIN SPF50 SPRAY 5OZ 12S

TN008KV

3/16/2021

00072140028800

CT P&S SPF50 SPRAY 5OZ 12S

TN00BR2

3/31/2021

00072140028817

CT P&S BABY SPF50 SPRAY 5OZ 12S

TN009GH

3/31/2021

00072140028824

CT P&S KIDS SPF50 SPRAY 5OZ 12S

TN00857

4/6/2021

00041100005069

CT SPORT SPRAY SPF50 1.6OZ 24S

TN00BU3

5/6/2021

00072140028800

CT P&S SPF50 SPRAY 5OZ 12S

TN00CJ4

6/15/2021

00072140028824

CT P&S KIDS SPF50 SPRAY 5OZ 12S

TN00CJV

6/15/2021

 

For product images, lot information, and refund requests, please see www.sunscreenrecall2021.com.

 

Benzene is classified as a human carcinogen. Exposure to benzene can occur through inhalation, oral, and skin and it could, depending on the level and extent of exposure, result in an increased risk of cancers including leukemia, and blood cancer of the bone marrow and other blood disorders which can be life-threatening. 

 

Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies. 

Out of an abundance of caution, the firm is recalling certain lots of these specific aerosol sunscreen spray products.  To date, Coppertone has not received any reports of adverse events related to this recall. 

 

The voluntarily recalled sunscreen spray products are packaged in aerosol cans.  The products were distributed nationally in the United States through various retailers.  Consumers should stop using these specific Coppertone aerosol sunscreen spray products and dispose of them appropriately.

 

Beginning on September 30, 2021 at 5pm (EST), consumers may contact 1-888-921-1537 with questions Monday to Friday from 8:30am-5pm (PT).    Consumers may also access www.sunscreenrecall2021.com to request a product refund and for additional information.  Coppertone is also notifying its retailers by letter and is arranging for returns of all voluntarily recalled lots of sunscreen spray products. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these aerosol sunscreen spray products.

 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

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4. B&G Foods announced that it is voluntarily recalling 3,867 cases of 23 oz. Tone’s Taco Seasoning Blend, with “best by” dates of SEPT 03 24 and SEPT 06 24, due to the presence of undeclared wheat. A portion of the individual containers within those cases were mistakenly labeled on the back with the back labels for Tone’s Lemon Pepper Seasoning Blend, which does not list wheat as an allergen. People who have an allergy or severe sensitivity to wheat run the risk of serious or life- threatening allergic reaction if the recalled product is consumed. There is no health risk associated with this product for individuals without an allergy or severe sensitivity to wheat.

 

This recall affects only the following product, which may have been distributed in Sam’s Club stores nationwide and through the Sam’s Club website:

 

Description

Consumer UPC #

Size

Best By Dates

Tone’s Taco
Seasoning Blend

UPC#: 0-41351-91461-5
(The UPC is located on the bottom
of the back label and references
the incorrect product.)

23 oz. (1.43 LB)
(653g)

SEPT 03 24
SEPT 06 24
(The “best by” date is
located on the bottom of
the side of the container.)

 

This recall does not apply to any other “best by” dates, sizes or varieties of Tone’s brand products.

 

No allergic reactions or consumer complaints related to this matter have been reported to date. This recall was initiated in cooperation with the FDA.

 

It was determined that 3,867 cases of Tone’s Taco Seasoning Blend, which contain wheat, may contain some individual containers which are mistakenly labeled on the back as Lemon Pepper Seasoning Blend, which does not declare wheat. The product name appears on the top of the front and back label. Containers labeled as Tone’s Taco Seasoning Blend on both the front and back of the container correctly declare the presence of wheat. Containers labeled as Tone’s Taco Seasoning Blend on the front and Lemon Pepper Seasoning Blend on the back do not list wheat as an allergen. Therefore, B&G Foods is issuing this recall for Tone’s Taco Seasoning Blend with the particular UPC and “best by” dates listed above.

 

Consumers who have purchased the recalled product can return it to the place of purchase for a full refund or dispose of the product. Consumers seeking a refund or additional information may also contact B&G Foods by calling 800.247.5251 Monday through Friday from 8:30 a.m. to 6:00 p.m. Eastern time or by submitting an online contact at https://tones.com/contact

 

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No action is required of local health departments at this time for any of these recalls. If any requests for assistance are received from FDA, the Public Health and Food Protection Program will contact you. For additional information regarding warnings and recalls, please click on the weblink below.

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For all recalls - http://www.recalls.gov/recent.html

 


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